Is It Possible to Predict Pre Term Labor by Measuring Cervical Length in the Non-pregnant Uterus?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01340352

Enrollment

Registered

2011-04-22

Start date

2011-05-31

Completion date

2015-01-31

Last updated

2015-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Brief summary

Working hypothesis and aims: To investigate the association between cervical length in non-pregnant women, and the risk of premature birth. The participants will be recruited from the HaEmek Medical Center delivery room registration. Women delivered between 24-37 pregnancy weeks will be allocated to the study group. The investigators will invite them 3 month or more after delivery to ultrasound examination of the cervical length. The participants in the control group will be the women whom term delivery follows by chronological manner to those in study group. Data of the cervucal length will be collected at the time of the examination.

Detailed description

Women will be invited to undergo an examination in Ultrasound Unit of Department of Obstetrics and Gynecology, HaEmek Medical Center. Ultrasound examination will be performed using the Voluson E8 device, General Electric. The cervical length,between the external and internal orifice will be measured using conventional technologies available including: Doppler, three dimensional and two dimensional ultrasound.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Nonpregnant women aged 18-40 years. * Singelton last pregnancy. * Last birth, spontaneous premature (24-37 week) * Last birth at least 3 months ago.

Exclusion criteria

* Presence of uterine malformations. * Sonographic pathologic findings. * Technical failure (failed appropiate sonographic visualisation) * Presence of fetal malformations ( in preterm delivery ) * Presence of comorbidities including diabetes, hypertension, collagen disease, thrombophilia * Presence of risk factors for premature delivery (amniotic fluid infection, * cervical surgical treatments - conization, polyhydramnios, etc.).

Design outcomes

Primary

Measure	Time frame	Description
length of the cervix in mm.	up to 20 month	External orifice location is well-defined anatomically and easy for identification .Internal orifice location will be determined by the level of the uterine arteries at both sides of the cervix.

Countries

Israel

Outcome results